Lilly’s Patient-Friendly Ready-to-Use once weekly GLP-1 agonist Trulicity approved in the US

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Twitter Summary: FDA approves Trulicity for #T2D, 1st ready-to-use once-weekly GLP-1 agonist in the US, with a patient-friendly “auto-injector” – launch for later this year

On September 18, the FDA approved Eli Lilly’s Trulicity (dulaglutide) for type 2 diabetes, making it the third once-weekly injectable GLP-1 agonist approved in the US after GlaxoSmithKline’s Tanzeum (albiglutide) and AstraZeneca’s Bydureon (exenatide). Eli Lilly plans to launch Trulicity later this year, available in both .75 mg and 1.5 mg doses. It is not recommended for anyone with a history of pancreatitis or severe gastrointestinal problems (e.g., gastroparesis). For more information on Trulicity’s side effects, please see its approved drug label. There is no word yet on reimbursement or pricing information for Trulicity.

Trulicity is truly a leap forward in terms of user convenience. The once-weekly GLP-1 agonists that are currently available require multiple steps and 15-30 minutes (mostly wait time) to prepare the injection. Trulicity is a once-weekly GLP-1 agonist that is ready-to-use out of the box in the same way that once-daily GLP-1 agonists already are. Additionally, it is available in a new type of injection device called a single-use pen or an “auto-injector” that allows users to never have to see a needle. Taking Trulicity is as simple as uncap, unlock, and inject: users take the cap off of the pen, twist one end to unlock, and then place the flat end of the pen to their skin. With the push of a single button, the pen inserts a previously hidden needle into the skin, administers the injection in a couple of seconds, and then withdraws the needle back into the device. This process strikes us as an enormous plus given the stress that “needle phobia” can cause. Although Lilly is the first company to receive approval for an auto-injector for its once-weekly GLP-1 agonist, other companies (including AstraZeneca) are working on their own auto-injectors as well.

Trulicity has the potential to transform the conversation that people with type 2 diabetes have with their providers when oral therapies are no longer enough to control their blood glucose. Currently, when reaching that point, many people choose to begin basal insulin. Lilly studied Trulicity in comparison with the basal insulin Lantus (insulin glargine), and found that Trulicity 1.5 mg provided greater reductions in A1c, weight loss benefits, and less hypoglycemia. Trulicity is also the first GLP-1 agonist to show similar efficacy to that of the once daily GLP-1 agonist Victoza (Novo Nordisk’s liraglutide). With such compelling clinical data and its remarkable ease of use, we can’t help but wonder if Trulicity could be used even earlier in the course of type 2 diabetes than other drugs in this class have been used until now. GLP-1 agonists provide important benefits to patients – strong glucose lowering with less hypoglycemia and weight gain – and we are glad that Trulicity will make this drug easier for people to take. –MV/AJW